Linking Infectious and Narcology Care-Part II

HIV Infection Clinical Trial

— LINC-II  

Official title:

Linking Infectious and Narcology Care-Part II

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03290391
• Other study ID #: H-36706
• Secondary ID: R01DA045547
• Status: Completed
• Phase: Phase 4
• Start date: September 19, 2018
• Est. completion date: April 6, 2022

Study information

• Verified date: March 2023
• Source: Boston Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study, "Linking Infectious and Narcology Care - Part II (LINC-II)," will implement and evaluate a multi-faceted intervention (LINC-II), via a two-armed randomized controlled trial among 240 HIV-infected PWID in St. Petersburg. LINC-II, comprised of pharmacological therapy (i.e., rapid access to ART and receipt of naltrexone for opioid use disorder) and 12 months of strengths-based case management, will assess HIV outcomes (e.g., HIV viral load suppression), impact on care systems and cost-effectiveness of the intervention.

Description:

Russia and Eastern Europe continue to have one of the fastest growing HIV epidemics in the world, with highest transmission risks among people who inject drugs (PWID) and their sexual partners. While routine HIV testing within addiction treatment systems in Russia (i.e., narcology hospitals) is the norm, links between the narcology and HIV care systems are limited and ineffective. In St. Petersburg 50-60% of PWID are HIV-infected, yet among this population less than 10% are on antiretroviral therapy (ART). For Russia to make progress toward the UNAIDS 90-90-90 targets (i.e., 90% aware of HIV diagnosis, 90% of those diagnosed on ART and 90% of those on ART with suppressed HIV viral load [HVL]), a bold new strategy is required. The objective of this study, "Linking Infectious and Narcology Care - Part II (LINC-II)," is to implement and evaluate, via a two-armed randomized controlled trial among 240 HIV-infected PWID, a multi-faceted intervention combining pharmacological therapy (i.e., rapid access to ART and receipt of naltrexone for opioid use disorder) and 12 months of strengths-based case management. The central hypothesis is that LINC-II will lead to marked progress toward the achievement of the 90-90-90 HIV cascade of care targets among HIV-infected PWID, relative to current standard of care, and that LINC-II will facilitate health system coordination of narcology and HIV care. LINC-II aims to: 1) evaluate the effectiveness of LINC-II on undetectable HVL at 12 months (primary outcome), initiation of ART within 28 days of randomization, change in CD4 count from baseline to 12 months, retention in HIV care (i.e., ≥ 1 visit to medical care in 2 consecutive 6 month periods), and undetectable HVL at 6 months; 2) evaluate the impact of LINC-II on coordinated care across the narcology and HIV health care systems, using mixed methods data from health care providers, administrators, and patients; and 3) evaluate the cost-effectiveness of the intervention to inform policy makers on scaling up the LINC-II approach both within Russia and other countries with HIV epidemics driven by injection drug use.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 225
• Est. completion date: April 6, 2022
• Est. primary completion date: April 6, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years or older
• HIV infected
• Hospitalized at narcology hospital
• History of injection drug use
• Current diagnosis of opioid use disorder
• Provision of information for 2 contacts to assist with follow-up
• Address within 100 kilometers of St. Petersburg
• Possession of a telephone (home or cell)
• Able and willing to comply with all study protocols and procedures

Exclusion Criteria:

• Not fluent in Russian
• Cognitive impairment
• Pregnancy, planning to become pregnant, or breastfeeding
• ART use in past 30 days prior to hospitalization
• Known hypersensitivity to naltrexone
• Acute severe psychiatric illness (i.e. ,answered yes to any of the following: past three month active hallucinations; mental health symptoms prompting a visit to the ED or hospital; mental health medication changes due to worsening symptoms; presence of suicidal ideations)
• Known history of liver failure
• ALT or AST >5 times the upper limit of normal
• Known severe thrombocytopenia (<50k)
• Known coagulation disorder/taking anticoagulation medications
• Body habitus that precludes intramuscular injection
• Known hypersensitivity to naloxone
• Known history of Raynaud's disease
• Known history of Itsenko-Cushing syndrome
• Known history of generalized mycoses
• Known history of glaucoma
• Known history of osteoporosis.
• Planned surgeries in the next 12 months

Related Conditions & MeSH terms

• Drug Use
• HIV Infection
• HIV Infections

Intervention

Other:
• Rapid ART initiation
The infectionist will streamline the approval with the ultimate goal of starting participants on ART while they are still hospitalized at the City Addiction Hospital.

Drug:
• Pharmacotherapy for opioid use disorder
Thirteen months of naltrexone treatment for opioid use disorder (injection at baseline, followed by 4 implants).

Behavioral:
• Strengths-based HIV case management
Strengths-based case management: 10 sessions over 12 months in which a trained case manager (CM) meets individually with patients to motivate them to engage in HIV medical care by supporting the recognition of their own strengths to make positive changes in their lives and ultimately improve their HIV outcomes.

Locations

Country	Name	City	State
Russian Federation	City Addiction Hospital	St. Petersburg
Russian Federation	First St. Petersburg Pavlov State Medical University	St. Petersburg

Sponsors (2)

Lead Sponsor	Collaborator
Boston Medical Center	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Undetectable HIV Viral Load at 12 Months	Number of participants with undetectable HIV viral load at 12 months, assessed by HIV viral load lab test (<40 copies per milliliter)	12 months post randomization
Secondary	Initiation of Antiretroviral Therapy (ART)	Number of participants who initiated ART within 28 days of randomization. Data will be extracted from medical record.	Within 28 days of randomization
Secondary	Change in Mean CD4 Count From Baseline to 12 Months	The change in the mean CD4 count (CD4 cells per cubic millimeter) will be calculated from the baseline and 12 months lab results	Change from baseline to 12 months
Secondary	Retention in HIV Care	Number of participants who had at least 1 visit to HIV medical care in 2 consecutive 6 month periods. Data will be extracted from medical record.	12 months
Secondary	Undetectable HIV Viral Load at 6 Months	Number of participants with undetectable HIV viral load at 6 months, assessed by HIV viral load lab test (<40 copies per milliliter).	6 months